The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

Alvision™ Interventional Cardiology Diagnostic Catheter Use for Routine Diagnostic Procedures in Angiographic Applications: Evaluation of Safety and Performance in Everyday Clinical Practice. The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Coronary Artery Disease; Coronary Disease
• Intervention / Treatment: Device: Alvision™ Interventional Cardiology Diagnostic Catheter

Detailed Description

Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Alvimedica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population will consist of all patients in which the Alvision™ Interventional Cardiology Diagnostic Catheter is used who meet the study inclusion/exclusion criteria.

Description

Inclusion Criteria:

• Turkish citizen,
• ≥18 years of age,
• Has indication for a diagnostic coronarography according to Alvision™ Instruction for use,
• Has signed and dated the informed consent.

Exclusion Criteria:

• Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter.
• Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
• Participating in another medical device or pharmaceutical clinical trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.		until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:	Thrombus formation/emboli; Arterial wall damage; Myocardial infarction; Plaque dislodgement; Cardiac arrhythmia; Death; Stroke	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of the successfully insertion catheter		until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Capacity of providing the doctor with a safe and effective tool to perform angiographies	Ratio of damage on vessels (%); Ratio of cardiogenic shock (%); Ratio of the straight course of the catheter through the vessels (%)	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality	Trackability (%); Torquability (%) ,; Slippage (%) ,	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume		until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Determination of the relation between catheter size, and patients' height.	catheter size (cm) patients' height (cm)	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure

Collaborators and Investigators

• Sponsor: Alvimedica

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Vascular Diseases
• Other Study ID Numbers: C42102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No